Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection

Not Applicable

Completed

Interventions: Other: restrictive perioperative fluid management
Other: Liberal perioperative fluid management

Brief Summary: The purpose of this study is to help us learn what the best amount of fluid is that patients should receive during pancreas surgery. Patients will receive either the liberal fluid amount for this surgery or a restricted fluid amount.

Both amounts of fluid have been used safely in patients having similar surgeries. These amounts have not been compared in pancreatic surgery. The fluids regimens that will be given are not experimental.

This study will compare patients in the liberal and restricted fluid groups in terms of the nature of any surgical complications (problems)and recovery from surgery, including length of hospital stay.

Recruitment & Eligibility

Inclusion Criteria

Adults > or = 18 years
Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal Pancreatectomy.

Exclusion Criteria

Pregnancy
History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal LV function within 30 days of operation
MI within 3 months
History of stroke
History of congestive heart failure and ejection fraction less than 35%
History of severe COPD and resting oxygen saturation (SpO2) < 90%
Renal dysfunction (Cr > 1.8)
Abnormal coagulation parameters (INR > 1.5 not on Coumadin, or platelet
Presence of active infection including HIV
BMI > 35
American Society of Anesthesiologists Status > III, assigned at time of preoperative visit
Corticosteroid use > 10 mg Prednisone/day
Bilirubin > 10.0

Arm && Interventions

Group	Intervention	Description
pts undergoing pancreatic resection Restrictive arm	restrictive perioperative fluid management	All patients will receive Normosol or equivalent solution, 0.5 ml/kg/fasted hour IV (approximately from 8am to time of induction) during induction of anesthesia. All patients will then receive maintenance fluids consisting of Normosol or equivalent solution at 6 ml/kg/operative hour. After randomization occurs, those patients randomized to the Restricted Arm will continue to receive Normosol or equivalent solution at 6ml/kg/operative hour.
pts undergoing pancreatic resection Liberal arm	Liberal perioperative fluid management	All patients will receive Normosol or equivalent solution, 0.5 ml/kg/fasted hour IV (approximately from midnight to time of induction) during induction of anesthesia. All patients will then receive maintenance fluids consisting of Normosol or equivalent solution at 6 ml/kg/operative hour. Those patients randomized to the Liberal Arm will receive an additional Normosol bolus or equivalent solution equal to (another) 1.5 ml/kg/fasted hour IV (to bring the total to 2 ml/kg/fasted hour) plus an additional bolus of Normosol or equivalent solution 6ml/kg/operative hour to bring the hourly rate to 12ml/kg/operative hour with a maximum of 1000 ml/operative hour.

Primary Outcome Measures

Name	Time	Method
To determine if restrictive perioperative fluid management results in fewer complications, morbidity and decreased length of stay in patients undergoing pancreatic resection, compared to liberal fluid management.	3 years

Secondary Outcome Measures

Name	Time	Method
Determine if restrictive perioperative fluid management, comp to liberal periop fluid management, decreases delayed gastric emptying, length of stay (LOS) & the incidence of other, less frequent morbidity in adult patients getting pancreatic resection.	3 years

Locations (1): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States

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